United StatesPhasitron 5 IPV In‑Line Valve (Intrapulmonary Percussive Ventilation), REF P5‑TEE‑20 (pack of 20) or P5‑TEE (individual) with In‑Line Valve and Instructions for Use P20020 Rev F, lots listed and UDI‑DI 00849436000723 is recalled. The pressure relief seal on the in‑line valve may leak when used with a ventilator, which can cause respiratory acidosis, hypoxemia, or respiratory failure; do not use these devices in neonates/infants or when target tidal volumes are under 50 mL or patients weigh under 10 kg, and follow the updated Instructions for Use for continued use until a design update is implemented.
What's being recalled
Phasitron 5, IPV In-Line Valve, (Intrapulmonary Percussive Ventilation) REF: P5-TEE-20 (pack of 20)/ P5-TEE (individual) with In-Line Valve Sentec Instructions for Use
Recalling firm: Percussionaire Corporation, Sandpoint, ID, United States.
How to identify it
UDI-DI: 00849436000723. Lots: 240326, 250116, 240418, 250324, 240610, 250616, 240620, 241121, 230612, 240826, WO04884, 241118, WO06020, 241203, WO05019, 250111, WO04827, WO04756. Instructions for Use P20020 Rev F
The hazard
IFU update; in-line valve, with pressure relief seal may leak when used with ventilator; don't use in neonates/infants, with target tidal volumes less-than50mL or less-than10kg- at high risk of cardiopulmonary/neurological compromise due to unrecognized hypoventilation, updates for continued use in others before design update; leak may cause respiratory acidosis, hypoxemia, or respiratory failure.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Worldwide distribution. US nationwide, Russia, Japan, Switzerland, Canada, Qatar, Chile, South Africa, United Kingdom, Israel, Turkey, and UAE
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)